Whitepapers2019-04-19T21:00:41+00:00

The Excel Problem: Picking the Right Tool for Product-Process Data Management

June 19th, 2020|Tags: , , , , , , , |

In the life science industry, like many sectors, Excel is a proverbial hammer. However not all problems are nails. Launched by Microsoft in the 80's, Excel has become ubiquitous as a tool for [...]

Leader in Restorative Cell Therapies Embeds Skyland PIMS® as Process Knowledge Base from Clinical to Commercial Manufacturing

June 5th, 2020|Tags: , , , , , , |

Overview A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. With more complex drug manufacturing processes, [...]

Skyland PIMS® Save Time and Costs in Development and Manufacturing Data Management with Innovative Technology

February 27th, 2020|Tags: , , , , , |

INTRODUCTION Managing disparate data across global manufacturing networks makes capturing, analyzing and sharing process data complex. While process data can be managed manually and with spreadsheets, this approach is error-prone, labor intensive, doesn’t [...]

Enabling Data Visibility in Contract Manufacturing Networks

October 23rd, 2019|Tags: , , , , , , |

Life Science manufacturing data management has become increasingly difficult with advancements in complex biotech and “precision” cell and gene therapies. Meanwhile, with performance metrics in manufacturing lagging those in other pharma operations, there’s [...]

Economic and Operational Advantages of Skyland PIMS® Cloud-based Data Collaboration Platform for Life Science Manufacturing

September 30th, 2019|Tags: , , , , , , |

Most organizations realize the “true cost” of any business investment is not the initial purchase price, but the Total Cost of Ownership (TCO). TCO measures initial costs plus ongoing costs including those that [...]

Skyland PIMS®: The Industry Standard for Managing and Sharing Process and Product Data with Sponsors

September 30th, 2019|Tags: , , , , , , |

For CDMOs, traditional challenges like capacity, margins, yield and capital requirements have been supplemented by new challenges. The growth in complex products such as biologics, cell and gene therapy and precision medicine has [...]

Smarter Manufacturing Data Management – Using Software Systems to Drive a Successful CPV Program

March 27th, 2019|Tags: , , , , , , |

Overview Data is prevalent through all functions of the Life Science industry. Its value impacts many disciplines throughout an organization, and while the use of data by discipline varies, it always involves: Gathering [...]

Unlocking the Value of Manufacturing Data at a CDMO

March 3rd, 2019|Tags: , , , , , , , |

65% of the FDA’s 2017 warning letters cited data integrity Consequently, this has put pressure on drug sponsors and their CDMOs to implement compliant data management systems that provide transparency, preserve customer confidentiality and [...]